
Regulatory Medical Content Developer
4 days ago
We are seeking a skilled Regulatory Medical Content Developer to join our team at the Medical Writer II level.
- This is a remote, hybrid, or office-based working option available.
About Us
- We are a leading Contract Research Organisation supporting drug development for the pharmaceutical and biotechnology industry.
Role Overview
- You will coordinate, write, and edit clinical documents including Investigator Brochures (IBs), Clinical Study Protocols (CSPs), Participant Information and Consent Forms (PICFs), and Clinical Study Reports (CSRs).
- You will serve as a primary technical contact for other departments and clients, mentor Medical Writers, and uphold quality standards.
Requirements & Qualifications
- Bachelor's degree in a scientific or relevant discipline.
- Higher degree desirable.
- At least 2 years of Medical Writing experience, including clinical trial documents.
- Minimum 3 years in the biotech/pharma/clinical research industry.
- Strong report writing skills and experience with peer-reviewed publications.
- Knowledge of ICH GCP, ICH E3 guidelines, medical terminology, and clinical trial processes.
- Knowledge of statistics and data analysis desirable.
- Knowledge of pharmacokinetics desirable.
- Excellent time management and organizational skills.
- Mentoring or leadership experience.
- Excellent communication skills.
- Proactive, reliable, and able to work independently.
- Supportive of a positive team culture.
- Proficient in MS Office.
Please submit your CV and cover letter as one Word document. You must have full Australian working rights to be considered.
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